(Q35802081)

10 August 2017

Clinical development of advanced therapy medicinal products in Europe: evidence that regulators must be proactive (English)

1 reference

10 August 2017

Romaldas Maciulaitis

1

1 reference

10 August 2017

Lucia D'Apote

2

1 reference

10 August 2017

Andrew Buchanan

3

1 reference

10 August 2017

Laura Pioppo

4

1 reference

10 August 2017

Christian K Schneider

5

1 reference

10 August 2017

1 March 2012

1 reference

10 August 2017

1 reference

10 August 2017

20

1 reference

10 August 2017

3

1 reference

10 August 2017

479-482

1 reference

Use of unregulated stem-cell based medicinal products.

10 August 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3293601

Stem-cell pioneer bows out.

11 July 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3293601

Challenges with advanced therapy medicinal products and how to meet them.

25 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3293601

European regulation tackles tissue engineering

25 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3293601

Comparison of different isolation techniques prior gene expression profiling of blood derived cells: impact on physiological responses, on overall expression and the role of different cell types.

25 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3293601

Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency

25 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=3293601

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the condu

15 November 2018

1 reference

PubMed

https://pubmed.ncbi.nlm.nih.gov/22378030

inferred from PubMed ID database lookup

12 December 2020

based on heuristic

Typical pitfalls in applications for marketing authorization of biotechnological products in Europe

1 reference

PubMed

https://pubmed.ncbi.nlm.nih.gov/22378030

inferred from PubMed ID database lookup

12 December 2020

based on heuristic

Identifiers

DOI

10.1038/MT.2012.13

1 reference

10 August 2017

1 reference

10 August 2017

PubMed publication ID

22378030

1 reference